BioMerieux VIDAS System in combination with Quality Control VIDAS* — Class II medical device recall Z-2429-2018
Terminated recall by bioMerieux, Inc., reported 2018-07-18, distributed nationwide. Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label
| Recall number | Z-2429-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2018-01-04 |
| Classified | 2018-07-12 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2022-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LK, LT, LV, MA, MT, MX, MY, NG, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SV, TH, TN, TR, UA, UY, VE, VN, ZA |
| Quantity | 1,866 units |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 03573026029678, 03573026030292, 03573026109257, 03573026114060, 03573026114084, 03573026121631, 03573026133573, 03573026133580, 03573026140427, 03573026351663, 03573026553319 |
Product
BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the mini VIDAS system is an immunodiagnostic system intended to be used by trained and qualified laboratory professionals, for In vitro Diagnostic (IVD) purpose, veterinary and industrial applications. The mini VIDAS¿ system is intended to execute an immunoassay protocol and to release results according to the package insert of the VIDAS¿ assay kits.
Reason for recall
Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS¿ and mini VIDAS¿ system due to a decrease of pipetted volume.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2429-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.